Certifications
We are certified to ISO 9001:2015 and ISO 15378:2017 standards, and operate in full compliance with current GMP requirements.
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Quality management system.
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Development and manufacture of plastic primary packaging for medical and pharmaceutical products.
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Our certification for the production of Class I Medical Devices according to Directive 93/42/EEC, Annex V, is currently on hold. But we have kept all procedures in place so we can readily undergo the re-certification audit and resume full compliance to manufacture Class I Medical Devices with CE-mark and with measuring function.